About this trial
This study will assess the adverse events and how oral ABBV-932 moves through the body when given with oral Itraconazole in adult participants with bipolar disorder.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Body Mass Index (BMI) ≥ 18.0 to ≤ 38.0 kg/m² after rounding to the tenths decimal. BMI is calculated as weight in kg divided by the square of height measured in meters.
A condition of general good health, based upon the results of a medical history, physical examination, vital signs, laboratory profile, and a 12-lead ECG
Participants with Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5-TR) primary diagnosis of bipolar I or II disorder as confirmed by the Mini International Neuropsychiatric Interview (MINI 7.0.2).
Disqualifiers
Clinical Global Impression-Severity (CGI-S) > 4 at Screening or Baseline.
History of psychiatric hospitalization (inpatient or intensive outpatient) in the past 3 months prior to screening.
Major depressive or manic episode within the past 3 months prior to screening.
Lifetime history of schizophrenia spectrum or other psychotic disorders, dissociative disorders, or neurocognitive disorders.
Trial design
Single group
Treatments tested in this trial
ABBV-932
DrugOral Capsule
Itraconazole
DrugOral Capsule
Treatment groups
Trial outcomes
Primary outcomes
Maximum Plasma Concentration (Cmax) of ABBV-932 and active metabolites DCAR and DDCAR
Cmax of ABBV-932 and active metabolites DCAR and DDCAR
Time to Cmax (Tmax) of ABBV-932 and active metabolites DCAR and DDCAR
Tmax of ABBV-932 and active metabolites DCAR and DDCAR
Observed plasma concentration at the end of a dosing interval (Ctrough) of ABBV-932 and active metabolites DCAR and DDCAR
Ctrough of ABBV-932 and active metabolites DCAR and DDCAR
Apparent terminal phase elimination rate constant (β) of ABBV-932 and active metabolites DCAR and DDCAR
(β) of ABBV-932 and active metabolites DCAR and DDCAR